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Anti-bacterial
Doxycycline Injection for Neurofibromatosis Type 2
Phase 1 & 2
Recruiting
Led By D. Bradley Welling, MD, PhD
Research Sponsored by Massachusetts Eye and Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 8 years on day 1 of treatment.
Patients must have a confirmed diagnosis of neurofibromatosis 2 by fulfilling National Institute of Health (NIH) criteria or Manchester criteria, or by detection of a causative mutation in the NF2 gene.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months, 1-year
Awards & highlights
Study Summary
This trial is testing a new, less invasive treatment for skin tumors caused by NF2. If successful, it could reduce the risks and costs of standard surgery.
Who is the study for?
This trial is for individuals aged 8 or older with neurofibromatosis type 2 (NF2) and skin schwannomas. Participants must have stable neurological conditions, a life expectancy over a year, and be able to give consent. They should not be on recent anticancer treatments or have severe medical issues that could affect participation.Check my eligibility
What is being tested?
The study tests local injections of Doxycycline directly into the skin tumors of NF2 patients as an alternative to surgery. The goal is to see if this method can effectively reduce tumor size while being less risky and costly than standard surgical procedures.See study design
What are the potential side effects?
Potential side effects may include typical reactions to doxycycline such as allergic responses, gastrointestinal upset, photosensitivity, headaches, dizziness, or local site reactions like pain and swelling at the injection area.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 8 years old or older.
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I have been diagnosed with neurofibromatosis 2.
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I can care for myself but may need occasional help.
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I have a visible schwannoma that can be measured.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-months, 1-year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months, 1-year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tumor Maximal Diameter
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single Arm Open LabelExperimental Treatment1 Intervention
Open Label
Find a Location
Who is running the clinical trial?
Massachusetts Eye and Ear InfirmaryLead Sponsor
106 Previous Clinical Trials
12,930 Total Patients Enrolled
D. Bradley Welling, MD, PhDPrincipal InvestigatorMassachusetts Eye and Ear Infirmary
1 Previous Clinical Trials
300 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 8 years old or older.My tumor is on my face or affects major nerves for movement.I haven't had radiation on the tumor I want to study in the last year or any radiation in the last 4 weeks.I have no lingering side effects from previous cancer treatments.I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.My neurological symptoms have been stable for at least a week.I am willing and able to follow the study rules.I have been diagnosed with neurofibromatosis 2.I can care for myself but may need occasional help.You are allergic to doxycycline or tetracycline.I have a visible schwannoma that can be measured.I haven't taken any cancer medications in the last 4 weeks.You are expected to live for more than 1 year.My cancer is quickly worsening and I need steroids for brain or spine tumor symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm Open Label
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many study participants are currently enrolled?
"That is correct. The clinical trial in question, which is seeking a total of 19 patients from 1 medical facility, is currently looking for participants according to the most recent update on September 27th, 2022."
Answered by AI
Is it possible to sign up for this research project at the present moment?
"This is an active trial, as reflected on clinicaltrials.gov. September 27th was the most recent update to the study information which was originally posted on September 19th, 2022."
Answered by AI
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